A Trial Evaluating the Clinical Applicability, Correlation, and Modeling of Cardiac CT Using 64 Detector Row VCT

Coronary Artery Disease Clinical Trial

Official title:

An Open-label, Non-randomized, Multi-center Trial Evaluating the Clinical Applicability, Correlation, and Modeling of Cardiac CT Using 64 Detector Row VCT

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00350506
• Other study ID #: VCT-001
• Status: Terminated
• Phase: N/A
• Start date: October 2005
• Est. completion date: October 2006

Study information

• Verified date: April 2019
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare computed tomography (CT) images (pictures) of the coronary arteries using the General Electric (GE) LightSpeed VCT scanner with x-ray coronary angiography in patients referred for an x-ray coronary angiography.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 77
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients scheduled for elective diagnostic catheterization OR

• Elective diagnostic catheterization has been performed within the past 2 weeks but no less than 24 hours prior to the coronary CTA procedure with no intervention performed or change of the patient clinical status.

• Age =18 years but =75 years.

Exclusion Criteria:

• Prior coronary stent implantation

• Prior coronary artery bypass grafting or other heart surgery

• Prior pacemaker or internal defibrillator lead implantation

• Prior artificial heart valve

• Biochemical renal insufficiency (CrSerum > 1.6) or on dialysis

• Resting HR > 100 at the time of enrollment

• Contraindication to ß-blockade or calcium channel blocker

• NYHA-IV

• High-grade atrioventricular (AV) block

• Systolic blood pressure <90 mm Hg

• Severe asthma or active bronchospasm and/or chronic obstructive pulmonary disease

• Atrial fibrillation

• Inability to provide informed consent

• Evidence of ongoing or active clinical instability

• Acute chest pain (sudden onset)

• Acute myocardial infarction

• Cardiac shock

• Acute pulmonary edema

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• 64 Channel VCT

Locations

Country	Name	City	State
United States	GE Healthcare	Princeton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
GE Healthcare

Country where clinical trial is conducted

United States,